NCT07517796

I.V Papavrine for Labor Induction in Term PROM

I.V Papavrine for Labor Induction in Term PROM: A Prospective Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This prospective randomized controlled trial aims to evaluate whether intravenous administration of papaverine 12 hours after term PROM reduces the interval from membrane rupture to delivery and improves maternal and neonatal outcomes. Researchers will compare drug papaverine to a placebo

Detailed description

Prelabor rupture of membranes (PROM) at term complicates approximately 8% of pregnancies and is associated with increasing maternal and neonatal infectious morbidity as the latency period to delivery lengthens. Consequently, most clinical guidelines recommend active management with labor induction within 24 hours following membrane rupture. Cervical status at the time of induction plays a critical role in labor outcomes, and women with an unfavorable cervix, commonly defined as a Bishop score below 8, are at increased risk of prolonged labor and induction failure. The uterine cervix is composed primarily of connective tissue, with smooth muscle accounting for approximately 15% of its structure and concentrated mainly beneath the internal cervical os. Papaverine is a musculotropic antispasmodic agent that acts directly on smooth muscle, leading to reduced muscle spasm and enhanced relaxation. The pharmacokinetic profile of papaverine includes a rapid onset of action within approximately 10 minutes and a short half-life of 0.5-2 hours, making it a potentially suitable adjunct during early labor. Antispasmodic agents have been shown to accelerate cervical dilatation and shorten the first stage of labor; however, their role in the management of term PROM has not been systematically evaluated. We therefore aim to investigate whether intravenous administration of papaverine in women with term PROM shortens the interval from membrane rupture to delivery and improves cervical ripening and maternal and neonatal outcomes.

Conditions

• Premature Rupture of Membranes

Interventions

Type	Name	Description
DRUG	Papaverine arm	given 12 houres after rupture of membranes
OTHER	Placebo	I.V seline

Timeline

• Start date: 2025-10-22
• Primary completion: 2027-10-22
• Completion: 2027-10-22
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: Israel